Physicians' Referrals to Health Care Entitles With Which They Have Financial Relationships and Supporting Regulations in 42 CFR, Sections 411.352, 411.354,411.355,411.357 and 411.361

Forms and Documents

Document Name	Status
Response to OMB Comments-11-16-07.doc Supplementary Document	2007-11-16
Updated PRA Justification-Phase III-11-19-07.doc Supporting Statement A	2007-11-19

IC Document Collections

IC ID	Document Title	Status
8655	Physicians' Referrals to Health Care Entitles With Which They Have Financial Relationships and Supporting Regulations in 42 CFR, Sections 411.352, 411.354,411.355,411.357 and 411.361	Modified

ICR Details

OMB Control No: 0938-0846	ICR Reference No: 200711-0938-007
Status: Historical Active	Previous ICR Reference No: 200407-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Physicians' Referrals to Health Care Entitles With Which They Have Financial Relationships and Supporting Regulations in 42 CFR, Sections 411.352, 411.354,411.355,411.357 and 411.361
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/12/2008
	Date Received in OIRA: 11/19/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	06/30/2008
Responses	154,404	0	62,824
Time Burden (Hours)	116,035	0	422,008
Cost Burden (Dollars)	0	0	0

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Abstract: Provisions under section 1877 of the Social Security Act prohibit a physician from referring a patient to an entity for a designated health service for which Medicare might otherwise pay if the physician or an immediate family member has a financial relationship with the entity, unless an exception applies. CMS implemented this section of the Act in regulations in 42 CFR Subpart J. The collection of information contained in these regulations is required by section 1877(f) of the Act. Respondents will be small businesses and other small entities, that is, physicians, providers, and suppliers, who are asked to record and maintain the information necessary to determine whether a prohibited financial relationship exists only when information changes.

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Authorizing Statute(s): US Code: 42 USC 1395 Name of Law: Prohibition of Certain Referrals
  

Citations for New Statutory Requirements: US Code: 42 USC 1395 Name of Law: Prohibition of Certain Referrals

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AK67	Final or interim final rulemaking	72 FR 51012	09/05/2007

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 34467	06/22/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 57034	10/05/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Physicians' Referrals to Health Care Entitles With Which They Have Financial Relationships and Supporting Regulations in 42 CFR, Sections 411.352, 411.354,411.355,411.357 and 411.361

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	154,404	62,824	0	91,580	0	0
Annual Time Burden (Hours)	116,035	422,008	-230,096	-75,877	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: In general, the numbers of physicians and hospitals have increased since the last information collection request (in CMS-1810-IFC); therefore, the information collection burden has changed for some sections. We have eliminated the requirement in section 411.357(s)that entities providing professional courtesy must notify insurance companies. We have reduced the estimated time for this burden.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 11/19/2007

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